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HCV clinical trials

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NCT ID: NCT03801707 Completed - Hepatitis C Clinical Trials

Utilization of Hepatitis C Positive Kidneys in Negative Recipients

Start date: March 22, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection

NCT ID: NCT03721627 Recruiting - Gaucher Disease Clinical Trials

Chronic Hepatitis C Treatment in Egyptian Children With Gaucher Disease.

Start date: April 3, 2018
Phase: Phase 4
Study type: Interventional

This prospective open label study is designed to screen all available Gaucher disease patients [either on enzyme replacement therapy (ERT) or not] for hepatitis C virus (HCV) infection. Furthermore to evaluate the safety and effectiveness of combined Sofosbuvir/Ledipasvir regimen given for 12 weeks in chronically infected patients aged 6-18 years.

NCT ID: NCT03572140 Not yet recruiting - HCV Clinical Trials

Safety of Sofosbuvir ,Daclatasvir in HCV Patients and RAVS in Resistent and Relapsed Cases

RAVs
Start date: July 1, 2018
Phase:
Study type: Observational

To identify side effects of Sofosbuvir/ Daclatasvir treatment regimen of chronic HCV GT-4 infection. - To assess the occurrence and the prevalence of RAVs in patients with treatment failure and relapse after sofosbuvir and daclatasvir with assessment of their types . - To examine the GT4 subtypes by phylogenetic analysis and baseline sequence variability among subtypes and their potential impact on treatment outcome and development of viral resistance in patients who received a regimen of Sofosbuvir/ Daclatasvir for treatment of chronic HCV GT-4. - To assess the differences in patient demographics across GT4 subtypes.

NCT ID: NCT03389061 Withdrawn - HCV Clinical Trials

Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet

CRUSADE-1
Start date: April 1, 2018
Phase: Phase 4
Study type: Interventional

Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. For patients with swallowing difficulties, administration of whole tablets can be problematic. In addition, HCV patients that are hospitalized (at intensive care units) due to severe illness (co-infections/ liver failure) might not be able to swallow medication. Therefore it is useful to know whether it is possible to administer SOF/VEL through a different route, like a feeding tube. In daily practice, information about the safety and efficacy of crushed tablets is lacking which might result in interruption or discontinuation of expensive HCV therapy. However, it is not recommended to interrupt treatment because there is no evidence about the efficacy of the therapy after discontinuation (and restart). Currently, patients and healthcare professionals are crushing SOF/VEL tablets without information about efficacy and safety. Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets can lead to altered pharmacokinetics of drugs. It is important to know whether pharmacokinetic parameters are influenced by crushing of tablets; both a decrease and an increase in exposure may occur. A decrease of the plasma concentrations of SOF and/or VEL potentially reduces the therapeutic effect of the drugs. Higher doses or switching to other HCV-drugs might be needed. In contrast, in case a higher Cmax,ss and/or exposure occurs there might be an increased risk of toxicity. As a result, crushing the drug is a contra-indication based on the available data. Therefore this study will be conducted to investigate whether a crushed SOF/VEL tablet is bioequivalent to SOF/VEL as a whole tablet.

NCT ID: NCT03362814 Completed - HCV Clinical Trials

Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Virus Genotype1 Infected Subjects.

Start date: July 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients.

NCT ID: NCT03288636 Completed - HCV Clinical Trials

Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

Start date: August 8, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the Pharmacokinetics and Safety of single dose of Ravidasvir and Danoprevir/r and repeated doses of Ravidasvir in combination with Danoprevir/r in healthy volunteers.

NCT ID: NCT03221309 Active, not recruiting - HCV Clinical Trials

Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior

ANCHOR
Start date: May 1, 2017
Phase:
Study type: Observational

This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use. Participants will be treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of opioid use disorder when clinically indicated.

NCT ID: NCT03105349 Withdrawn - HCV Clinical Trials

A Clinical Trial of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotypes 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A

C-RESCUE
Start date: July 1, 2017
Phase: Phase 4
Study type: Interventional

This is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the NS5A

NCT ID: NCT03092375 Completed - Hepatitis C Clinical Trials

Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects

Start date: April 20, 2017
Phase: Phase 3
Study type: Interventional

The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.

NCT ID: NCT03069001 Completed - HCV Clinical Trials

Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

Start date: June 2015
Phase: Phase 4
Study type: Interventional

This prospective study was conducted at Ain Shams University Hospital, Internal Medicine, Hepatology and Gastroenterology Department, and Tropical Medicine Department. To compare the efficacy of the combination of sofosbuvir and simeprevir for 12 weeks with the combination of sofosbuvir and ribavirin for 24 weeks in Egyptian patients with HCV-related Child A cirrhosis.